NICE says OK to Opdivo for lung cancer via CDF

Comes after BMS drops the price of its PD-1 inhibitor

Lung cancer patients in England will be able to get access to Bristol-Myers Squibb's Opdivo after the pharma company offered to reduce its price.

NICE has ruled that Opdivo (nivolumab) can be made available through the Cancer Drugs Fund (CDF) as a second-line therapy for patients with advanced non-small cell lung cancer (NSCLC), after chemotherapy, having earlier turned down routine NHS use of the PD-1 inhibitor.

The cost-effectiveness monitor took its decision on the strength of data showing that BMS' drug is life-extending for patients whose tumours express higher levels of the biomarker PD-L1, and after the company offered to make Opdivo available at a discount while it conducts trials to gather more evidence of its benefits. Now, around 1300 NSCLC eligible patients will be in line for treatment with the drug.

The earlier rejection was met with consternation by patients and medical charities, with more than 270,000 people signing two separate petitions - handed in to NICE last November - urging the agency to make the drug available.

"We know that nivolumab is clinically effective for some people with lung cancer but the full extent of its benefit is not clear," commented Prof Carole Longson, director of the NICE centre for health technology evaluation.

"This new deal means that we can give patients access to what we know is a promising treatment whilst more evidence is gathered on its value."

That view was backed by Prof Paul Workman, chief executive of the Institute of Cancer Research in London, who said that initially the drug was priced far too high to ever have been judged cost-effective by NICE.

"Companies need to come to the table with their best, most realistic price offer right at the start, so we get new exciting drugs, such as immunotherapies, to patients as quickly as possible," he said.

The cost of Opdivo depends on a person's weight and their type of lung cancer, but as an example someone weighing 73kg would require around £5,300-worth of the drug for a month's treatment.

Despite offering an undisclosed reduction in price, BMS has previously been vocal in its criticism of the decision to limit use of the drug to patients whose tumours express higher levels of PD-L1, arguing that the restriction is "inconsistent with the clinical evidence".

It's now adopted a more conciliatory tone. Benjamin Hickey, the company's UK and Ireland general manager, said the new recommendation "is excellent news and now allows access to an immunotherapy for more advanced lung cancer patients than ever before".

“We will track longer term data with the ultimate goal of ensuring that all advanced lung cancer patients could ultimately access nivolumab," he added.

Data from the CheckMate-057 trial showed that Opdivo extended the survival period for NSCLC patients with high PD-L1 status by seven months more than those with lower expression, but overall, 39% of Opdivo-treated patients were still alive after 18 months compared with just 23% of patients treated with the standard docetaxel chemotherapy.